Title: Moxetumomab Pasudotox-tdfk (Lumoxiti ) and Rituximab (Rituxan ) for Relapsed Hairy Cell Leukemia
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|ClinicalTrials.gov Identifier: NCT03805932|
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : May 7, 2020
Hairy cell leukemia (HCL) is a rare, slow-growing blood cancer in which the bone marrow makes too many of certain white blood cells. The antibody Rituximab binds to a protein in cancerous white blood cells and is often used to treat HCL. Researchers want to see if combining it with the drug Moxetumomab pasudotox-tdfk (also called Lumoxiti) can fight HCL better.
To test the safety of Moxetumomab pasudotox taken with Rituximab for people with HCL or HCL variant.
People age 18 years and older with HCL or HCL variant that has not responded to standard therapy
Participants will be screened with:
Blood, heart, and urine tests
Test of blood oxygen levels
Review of bone marrow. This can be from previous test results or a new sample.
Participants will get the study drugs in up to 8 cycles. A cycle will last about 28 days.
Both drugs will be given through a plastic tube in a vein.
In the first week of cycle 1, participants will have:
1 visit to get Rituximab for 7.5 hours
3 visits to get Lumoxiti for 30 minutes per infusion
In the first week of cycles 2-8, participants will have:
- visit to get Rituximab for 2-4 hours and Lumoxiti for 30 minutes
- visits to get Lumoxiti for 30 minutes per infusion
Participants will be asked to drink lots of water and take aspirin during the cycles. They will get drugs to minimize allergic reactions.
Participants will repeat screening tests at visits throughout the cycles and 1 follow-up visit. They may have an eye exam.
Sponsoring Institute: National Cancer Institute
|Condition or disease||Intervention/treatment||Phase|
|Hairy Cell Leukemia||Drug: Moxetumomab Pasudotox-tdfk Biological: Rituximab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Moxetumomab Pasudotox-tdfk (Lumoxiti (TM)) and Rituximab (Rituxan (R)) for Relapsed Hairy Cell Leukemia|
|Actual Study Start Date :||October 3, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Moxetumomab Pasudotox-tdfk + Rituximab
Drug: Moxetumomab Pasudotox-tdfk
Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg iv over 30 min given on days 1, 3, 5 of each cycle.
Rituximab will be administered at 375mg/m(2) iv, 50- 400 mg/hr. On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.
- Safety and Toxicity [ Time Frame: 4 weeks ]Determine recommended safe dose of moxetumomab pasudotox-tdfk and rituximab
- Response duration [ Time Frame: 1, 2 and 3.5 years after EOT, then every 2 years ]Time of initial response until documented tumor progression
- MRD-free rates [ Time Frame: 1, 2 and 3.5 years after EOT, then every 2 years ]Percentage of patients without minimal residual disease
- Response Rate [ Time Frame: 1, 2 and 3.5 years after EOT, then every 2 years ]Percentage of patients whose cancer shrinks or disappears after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805932
|Contact: Julie C Feurtado, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Robert J Kreitman, M.D.||National Cancer Institute (NCI)|